Postoperative Pain Management in Cerebral Palsy - Comparative Observational Study"

Sponsor
Biruni University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05252650
Collaborator
(none)
130
1
5.6
23.1

Study Details

Study Description

Brief Summary

In this study, our aim is to examine orthopedic interventions, anesthesia method, postoperative pain level and management applied to patients with CP in biruni university hospital.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: pain

Study Design

Study Type:
Observational
Anticipated Enrollment :
130 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Postoperative Pain Management in Pediatric Patients With Cerebral Palsy - Comparative Observational Study"
Anticipated Study Start Date :
Feb 15, 2022
Anticipated Primary Completion Date :
Jul 28, 2022
Anticipated Study Completion Date :
Aug 5, 2022

Arms and Interventions

Arm Intervention/Treatment
regional block

epidural / peripheral nerve block

Behavioral: pain
postoperative pain

intravenous

intravenous analgesia

Behavioral: pain
postoperative pain

Outcome Measures

Primary Outcome Measures

  1. pain score [6 month]

    pain score with r-FLACC

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosed with cerebral palsy between the ages of 3-15,

  • Category 2 according to the Classification of the American Society of Anesthesiology (ASA 2),

  • patients undergoing soft tissue release for knee or ankle flexion contracture of the lower extremity with palliative or reconstructive hip interventions

Exclusion Criteria:
  • Any child with CP younger than 3 years old and older than 15 years has undergone

  • procedures without a specific diagnosis of CP,

  • the need for bone surgery,

  • requiring both hip, knee and ankle surgery in the same session,

  • with autonomic neuropathy,

  • Patients with a history of anticholinergic and vasoactive drug use or allergy to amide type local anesthetics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ilke Kupeli Istanbul Turkey 34250

Sponsors and Collaborators

  • Biruni University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ILKE KUPELI, investigator, Biruni University
ClinicalTrials.gov Identifier:
NCT05252650
Other Study ID Numbers:
  • biruni cp
First Posted:
Feb 23, 2022
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022